510(k) Report

FDA applicant

Xanacare Technologies, LLC

Golden, CO3 decisions2008–20160 recalls

FDA records 3 decisions for Xanacare Technologies, LLC (Golden, CO) from 2008 to 2016: 3 510(k) clearances. All are in product code GZJ (Stimulator, Nerve, Transcutaneous, For Pain…). Its devices cite 10 predicates, 3 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Xanacare Technologies, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 22016: 1
2008high 2 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Xanacare Technologies, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Xanacare Technologies, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief3decisions

Whose devices does it build on?

Its devices cite 10 predicates; 3 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 3 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K081141Combocare 2000Xanacare Technologies, LLC · 20084cite it
  • K083202Combocare 2000Xanacare Technologies, LLC · 20082cite it

What has FDA decided for it lately?

  • K160246SimulCare II (TM)Xanacare Technologies, LLC · 2016
  • K083202Combocare 2000Xanacare Technologies, LLC · 2008
  • K081141Combocare 2000Xanacare Technologies, LLC · 2008

All 3 as Xanacare Technologies, LLC →